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- Publisher Website: 10.1016/j.cllc.2023.09.005
- Scopus: eid_2-s2.0-85175302357
- PMID: 37914594
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Article: TARGET: A Phase II, Open-Label, Single-Arm Study of 5-Year Adjuvant Osimertinib in Completely Resected EGFR-Mutated Stage II to IIIB NSCLC Post Complete Surgical Resection
Title | TARGET: A Phase II, Open-Label, Single-Arm Study of 5-Year Adjuvant Osimertinib in Completely Resected EGFR-Mutated Stage II to IIIB NSCLC Post Complete Surgical Resection |
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Authors | |
Keywords | Early-stage Epidermal growth factor receptor mutations Non-small cell lung cancer Targeted treatment Tyrosine kinase inhibitor |
Issue Date | 3-Oct-2023 |
Publisher | Elsevier |
Citation | Clinical Lung Cancer, 2023, v. 25, n. 1, p. 80-84 How to Cite? |
Abstract | Introduction: Osimertinib is a central nervous system (CNS)-active, third generation, irreversible, epidermal growth factor receptor tyrosine kinase inhibitor (EGFR-TKI) that potently and selectively inhibits EGFR-TKI sensitizing and EGFR T790M resistance mutations, with demonstrated efficacy in EGFR-mutated (EGFRm) non-small cell lung cancer (NSCLC). We present the rationale and design for TARGET (NCT05526755), which will evaluate the efficacy and safety of 5 years of adjuvant osimertinib in patients with completely resected EGFRm stage II to IIIB NSCLC. Materials and Methods: TARGET is a phase II, multinational, open-label, single-arm study. Adults aged ≥18 years (Taiwan ≥20 years), with resected stage II to IIIB NSCLC are eligible; prior adjuvant chemotherapy is allowed. Eligible patients must have locally confirmed common (exon 19 deletion or L858R) or uncommon (G719X, L861Q, and/or S768I) EGFR-TKI sensitizing mutations, alone or in combination. Patients will receive osimertinib 80 mg once daily for 5 years or until disease recurrence, discontinuation or death. The primary endpoint is investigator-assessed disease-free survival (DFS) at 5 years (common EGFR mutations cohort). Secondary endpoints include: investigator-assessed DFS at 3 and 4 years; overall survival at 3, 4, and 5 years (common EGFR mutations cohort); DFS at 3, 4, and 5 years (uncommon EGFR mutations cohort); safety and tolerability, type of recurrence and CNS metastases (both cohorts). Exploratory endpoints include: tissue/plasma concordance; analysis of circulating molecules in plasma samples using different profiling approaches to detect minimal residual disease; incidence and change over time of incidental pulmonary nodules. Results: TARGET is currently recruiting, and completion is expected in 2029. |
Persistent Identifier | http://hdl.handle.net/10722/345978 |
ISSN | 2023 Impact Factor: 3.3 2023 SCImago Journal Rankings: 1.263 |
DC Field | Value | Language |
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dc.contributor.author | Soo, Ross Andrew | - |
dc.contributor.author | de Marinis, Filippo | - |
dc.contributor.author | Han, Ji Youn | - |
dc.contributor.author | Ho, James Chung Man | - |
dc.contributor.author | Martin, Emma | - |
dc.contributor.author | Servidio, Leslie | - |
dc.contributor.author | Sandelin, Martin | - |
dc.contributor.author | Popat, Sanjay | - |
dc.date.accessioned | 2024-09-05T00:30:14Z | - |
dc.date.available | 2024-09-05T00:30:14Z | - |
dc.date.issued | 2023-10-03 | - |
dc.identifier.citation | Clinical Lung Cancer, 2023, v. 25, n. 1, p. 80-84 | - |
dc.identifier.issn | 1525-7304 | - |
dc.identifier.uri | http://hdl.handle.net/10722/345978 | - |
dc.description.abstract | Introduction: Osimertinib is a central nervous system (CNS)-active, third generation, irreversible, epidermal growth factor receptor tyrosine kinase inhibitor (EGFR-TKI) that potently and selectively inhibits EGFR-TKI sensitizing and EGFR T790M resistance mutations, with demonstrated efficacy in EGFR-mutated (EGFRm) non-small cell lung cancer (NSCLC). We present the rationale and design for TARGET (NCT05526755), which will evaluate the efficacy and safety of 5 years of adjuvant osimertinib in patients with completely resected EGFRm stage II to IIIB NSCLC. Materials and Methods: TARGET is a phase II, multinational, open-label, single-arm study. Adults aged ≥18 years (Taiwan ≥20 years), with resected stage II to IIIB NSCLC are eligible; prior adjuvant chemotherapy is allowed. Eligible patients must have locally confirmed common (exon 19 deletion or L858R) or uncommon (G719X, L861Q, and/or S768I) EGFR-TKI sensitizing mutations, alone or in combination. Patients will receive osimertinib 80 mg once daily for 5 years or until disease recurrence, discontinuation or death. The primary endpoint is investigator-assessed disease-free survival (DFS) at 5 years (common EGFR mutations cohort). Secondary endpoints include: investigator-assessed DFS at 3 and 4 years; overall survival at 3, 4, and 5 years (common EGFR mutations cohort); DFS at 3, 4, and 5 years (uncommon EGFR mutations cohort); safety and tolerability, type of recurrence and CNS metastases (both cohorts). Exploratory endpoints include: tissue/plasma concordance; analysis of circulating molecules in plasma samples using different profiling approaches to detect minimal residual disease; incidence and change over time of incidental pulmonary nodules. Results: TARGET is currently recruiting, and completion is expected in 2029. | - |
dc.language | eng | - |
dc.publisher | Elsevier | - |
dc.relation.ispartof | Clinical Lung Cancer | - |
dc.rights | This work is licensed under a Creative Commons Attribution-NonCommercial-NoDerivatives 4.0 International License. | - |
dc.subject | Early-stage | - |
dc.subject | Epidermal growth factor receptor mutations | - |
dc.subject | Non-small cell lung cancer | - |
dc.subject | Targeted treatment | - |
dc.subject | Tyrosine kinase inhibitor | - |
dc.title | TARGET: A Phase II, Open-Label, Single-Arm Study of 5-Year Adjuvant Osimertinib in Completely Resected EGFR-Mutated Stage II to IIIB NSCLC Post Complete Surgical Resection | - |
dc.type | Article | - |
dc.identifier.doi | 10.1016/j.cllc.2023.09.005 | - |
dc.identifier.pmid | 37914594 | - |
dc.identifier.scopus | eid_2-s2.0-85175302357 | - |
dc.identifier.volume | 25 | - |
dc.identifier.issue | 1 | - |
dc.identifier.spage | 80 | - |
dc.identifier.epage | 84 | - |
dc.identifier.eissn | 1938-0690 | - |
dc.identifier.issnl | 1525-7304 | - |